Profiles

Jacque Nalley

Research Coordinator

TRAININGS & QUALIFICATIONS

  • Electronic diaries: sponsor/vendor training (3 yrs)
  • CSSR-S: sponsor/national training; (certificate available)
  • Centrifuge: training by site, including cup size, RPMs, & calibrations (5 yrs)
  • EKG acquisition: site training per cardiologist; lead placement per sponsor recommendations; (5yrs)
  • EKG transmission: sponsor/vendor training; both computer/phone line (5 yrs)
  • CPR: BLS certificate
  • Vitals: include temp, WT, HT, BP, HR; site training; manual/automatic BP; oral, temporal, auricle temp (5 yrs)
  • IATA: computer training; current certificate holder
  • PHT SitePad: training per sponsor/vendor (1.5 yrs)
  • EDC Experience: sponsor training; includes Medidata Rave, Pfizer OC RDC, Forest (5 yrs)
  • IXRS: sponsor training; includes IRT plus, Trident, PPDI, Bracket, Perspective MyTrials, and ClinPhone (5 yrs)
  • GCP CITI: current certificate holder
  • Transmission of ultrasound including TVU, TAU, X-ray, CT scan, nuclear medicine, echo, DEXA via Dicom format (4 yrs)
  • MiniMental: sponsor training/national training (5 yrs)
  • Questionnaires: sponsor/national training; includes Treatment Continuation Assessment
  • Rapid Result Labs: include drug screening, nicotine, pregnancy, urine dip stick (5 yrs)
  • Blood Draws (5 yrs)
  • Lab Sample processing: sponsor, central lab specific, local lab, & site training (5 yrs)

CLINICAL RESEARCH

  • A multicenter, randomized, double-blind, parallel-group, placebo-controlled study evaluating the efficacy, safety and pharmacokinetics of SAGE-217 in the treatment of adult female’s subjects with severe postpartum depression.  SAGE 217-PPD-201
  • A multicenter, double-blind, placebo-controlled study evaluating the efficacy, safety, tolerability and pharmacokinetics or brexanolone in the treatment of adolescent female subjects with postpartum depression.  SAGE 547-PPD-304
  • A Multi-Center, randomized, double-blind, parallel group, placebo-controlled, study evaluating the efficacy, safety and pharmacokinetics of SAGE 547-PPD-202 injection in the treatment of adult female subjects with severe postpartum depression and adult female subjects with moderate postpartum depression.  SAGE 547-PPD-202
  • An open-label, parallel-group, randomized, multicenter study to assess the safety and efficacy of Vilaprisan in subjects with uterine fibroids versus standard of care.  BAYER 16953
  • A Phase 3, Multi-Center, Placebo-controlled, randomized, double-blind, 12-week study with a 40-week active controlled, double-blind extension to evaluate the efficacy and safety of K-877 in adult patients with fasting Triglcercide levels > or equal to 500 mg/dL and <200 mg/dL and normal renal functions. KOWA 301
  • A Phase 3, Multi-Center, placebo-controlled, randomized, double-blind 12-week study with a 40-week active controlled, open-label extension to evaluate the efficacy and safety of K-877 in adult patients with fasting Triglycercide levels > or equal to 500 mg/dL and <200 mg/dL aand mild to moderate renal impairment. KOWA 303
  • A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effect of long-term treatment with BELVIQ (lorcaserin HCI) on the incidence of major adverse cardiovascular events and conversion to type 2 diabetes Mellutis in obese and overweight subjects with cardiovascular disease or multiple cardiovascular risk factors.  TIMI 61
  • A Phase 3, randomized, open-label, comparative safety and efficacy trial to intravenous iron Isomaltoside (MONOFER) and iron sucrose in subjects with iron deficiency anemia and non-dialysis – dependent chronic kidney disease. CKD-04
  • A Phase 3, randomized, open-label, comparative safety and efficacy trial to intravenous iron isomaltoside (MONOFER) and iron sucrose in subjects with iron deficiency anemia who are intolerant or unresponsive to oral therapy or in whom the hemoglobin measurement in Investigator’s opinion were sufficiently low as to require repletion of iron stores to minimize the risk of receiving a blood transfusion. IDA-03
  • A multi-national, randomized, double-blind, placebo-controlled trial to evaluate the effect of Ticagrelor twice daily on the incidence of cardiovascular death, Myocardial infarction or stroke in patients with Type 2 Diabetes Mellutis.  THEMIS
  • A Phase 3, double-blind, randomized, placebo-controlled study to evaluate the effects of Dalcetrapib on cardiovascular (CV) risk in a genetically defined population with a recent Acute Coronary Syndrome (ACS): The Dal-GenE Trial DAL-301
  • A Phase 3 Study to Evaluate the Efficacy and Safety of Elagolix in Combination with Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated with Uterine Fibroids in Premenopausal Women.  AbbVie M12-815
  • A randomized, double-blind, placebo-and active-controlled study of DS-5565 in subjects with pain associated with fibromyalgia.  DS5565-A-E310
  • An open-label extension study of DS-5565 for 52 weeks in pain associated with fibromyalgia DS5565-A-E312
  • A parallel group, double-blind, randomized, placebo controlled, trial to evaluate the efficacy and safety of ALD403 administered intravenously in patients with frequent episodic migraines.  ALD403-CLIN-006
  • A randomized, open-label, parallel group real world pragmatic trial to assess the clinical and health outcomes of Toujeo® compared to commercially available basal insulins for initiation of therapy in insulin naïve patients with uncontrolled type 2 diabetes mellitus LPS14347
  • A randomized, double-blind, active-controlled study of Canakinumab (ACZ885) pre-filled syringes or reconstituted Lyophilizate versus Triamcinolone Acetonide for treating acute gouty arthritis flares in frequently flaring patients. Regeneron
  • A multi-center, randomized, double-blind, placebo-controlled study of the safety and efficacy of

long-term Rilonacept Treatment for the prevention of gout flares.  2361

  • A 36-week open-label extension study of CACZ885H2361 on the safety and tolerability of

Canakinumab 150 mg s.c. prefilled syringe (PFS) in treating acute gouty arthritis flares in

frequently flaring patients.  2361 E1

  • A multicenter, randomized, active-control, phase 3B study to evaluate the cardiovascular

safety of Febuxostat and Allopurinol in subjects with gout and cardiovascular comorbidities.  301

  • A double-blind, randomized, placebo-controlled, parallel-group study to evaluate the effect of Roflumilast 500 mg on exacerbation rate in patients with chronic obstructive pulmonary disease (COPD) treated with a fixed-dose combination of long-acting beta agonist and inhaled corticosteroid (LABA/ICS). ROF
  • A multi-center, randomized, double-blind, placebo and active-controlled, phase 3 study to evaluate the efficacy and safety of TAK-875 25mg and 50mg compared to placebo and Sitagliptin 100mg when used in combination with Metformin in subjects with Type 2 Diabetes.  302
  • Observational study of the use of Krystexxa (Pegloticase) in adult hyperuricemic patients with gout refractory to conventional therapy.  Krystexxa
  • A Randomized, Double-Blind, Parallel Design, Multiple-Site Study to Evaluate the Clinical

Equivalence of Ciprofloxacin 0.3%/Dexamethasone 0.1% Sterile Otic Suspension (Par) Compared to CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) Sterile Otic Suspension (Alcon) in the Treatment of Acute Bacterial Otitis Media in Children with Patent Tympanostomy Tubes. Otits Media

  • A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Daily Oral Fasiglifam 25 mg and 50 mg Compared to Placebo When Used in Combination with Sitagliptin in Subjects with Type 2 Diabetes. 303